o Manage study documents such as study level, country level and site level
o Maintain study databases (CTMS, IWRS, EDC etc.)
o Support study team in e-TMF management activities
o Support study team in data review and support activities
o Upload, check, correct and maintain study documents for document review in the study eTMF regionally.
§ Send study documents for document review to eTMF archivist after release
§ Provide study documents for document review to the client as per study specific Investigator Package Plan
§ Perform tracking and data entry activities related to document review
§ Maintain and update document tracking information in CTMS and/or other tracking logs/systems
§ Perform administrative tasks required during the study (e.g. archiving, return files to client at end of the study)
o To complete required trainings according to required timelines.
§ To complete day-to-day tasks ensuring quality and productivity.
§ To maintain project and technical documentation in an appropriate manner.
§ To perform checks to ensure quality of work completed
§ To ensure timely escalation as needed.
§ To assist in the document management (including document template creation, collection, review, processing and tracking up to eTMF filing) for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study duration
o To assist the study, start up teams with tasks required for site start up activities.
§ To manage and support assigned studies for upload as per set objectives
§ To follow up with study team on uploading queries
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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